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BioPharmaceutical North America United States

Tighter REMS For Zohydro ER Still Insufficient For FDA Advisory Panel

This article was originally published in The Pink Sheet Daily

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Executive Summary

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee wants Risk Evaluation and Mitigation Strategies enhanced for all extended-release/long-acting opioids as it recommends 11-2, one abstention, against approval of Zogenix’s single-entity hydrocodone product.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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